AquaVac ERM Concentrate for Dip Suspension for Rainbow Trout

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv ingrediens:

Yersinia ruckeri

Tilgjengelig fra:

MSD Animal Health UK Limited

ATC-kode:

QI10BB03

INN (International Name):

Yersinia ruckeri

Legemiddelform:

Concentrate for dip suspension

Resept typen:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Terapeutisk gruppe:

Trout - Golden/Rainbow/Redband/Steelhead

Terapeutisk område:

Inactivated Bacterial Vaccine

Autorisasjon status:

Authorized

Autorisasjon dato:

2004-08-03

Preparatomtale

Revised: August 2020
AN: 00299/2020
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AquaVac ERM
Concentrate for dip suspension for Rainbow trout
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE :
Inactivated cells of _Yersinia ruckeri_
(Hagerman type I strain)
RPS(*) ≥ 75% after vaccination
EXCIPIENT:
Formaldehyde:
≤ 0.5 mg/ml
*RPS : relative percentage of survival in Rainbow Trout
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for dip suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Rainbow trout (_Oncorhynchus mykiss)_
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In Rainbow Trout of 2 grams weight or over: Active immunization
against Enteric
Redmouth disease (ERM) to reduce mortality caused by the Hagerman Type
I strain of
_Yersinia ruckeri._
336 degree days are required for the development of full immunity (28
days at a water
temperature of 12°C). The time for development of protective immunity
will depend on
water temperature.
A duration of immunity of 78 days has been shown under laboratory
conditions.
Under field conditions, protection may be expected for at least 6
months. A booster
vaccination administered 4 months after primary vaccination may induce
a better level of
protection.
Revised: August 2020
AN: 00299/2020
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4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS
Only vaccinate healthy fish.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
During vaccination, the temperature of the diluted vaccine should not
differ from the water
temperature in the holding area by more than ± 5
o
C.
Fish should be subject to the minimum of manipulations such as sorting
and transportation
during the periods shortly before and after vaccination
SPECIAL
PRECAUTIONS
TO
BE
TAKEN
BY
THE
PERSON
ADMINISTERING
THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Personal protective equipment consisting of rubber gloves should be
worn during all
vaccination operations.
4.6
ADVERSE REACTIONS (FREQ